Trial Outcomes & Findings for Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration (NCT NCT01027468)

NCT ID: NCT01027468

Last Updated: 2019-04-24

Results Overview

Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: 3 years after first intravitreal bevacizumab treatment
• Results posted on: 2019-04-24

Participant Flow

Medical University of Vienna, Department of Ophthalmology during September 2008-July 2009 with a mean of 3 year follow-up after initial Bevacizumab intravitreal treatment

Inclusion criteria: * patients treated with bevacizumab due to wet age-related macular degeneration * follow-up of 3 years Exclusion criteria: - patients with other macular diseases

Participant milestones

Measure	Group 1 3 year follow-up of patients with intravitreal application of bevacizumab: From August 2005 to July 2006: 1 mg (0.04 mL) of bevacizumab After July 2006: 2.5 mg (0.1 mL) of Bevacizumab Follow-up intervals: 6-8 weeks
Overall Study STARTED	160
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration

Baseline characteristics by cohort

Measure	Group 1 n=160 Participants 3 year follow-up of intravitreal application of bevacizumab
Age, Customized	77.24 years STANDARD_DEVIATION 10.56 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years after first intravitreal bevacizumab treatment

Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis

Outcome measures

Measure	Group 1 n=160 Participants 3 year follow-up of intravitreal application of bevacizumab
Vision	0.16 logMAR Standard Deviation 0.21

PRIMARY outcome

Timeframe: 3 years after initial intravitreal bevacizumab treatment

Central retinal thickness measured in µm

Outcome measures

Measure	Group 1 n=160 Participants 3 year follow-up of intravitreal application of bevacizumab
CRT (Central Retinal Thickness)	319 µm Standard Deviation 110

SECONDARY outcome

Timeframe: 3 years after initial bevacizumab treatment

Outcome measures

Measure	Group 1 n=160 Participants 3 year follow-up of intravitreal application of bevacizumab
Systemic Complications After Treatment Retinal Detachment	0 participants
Systemic Complications After Treatment Endophthalmitis	0 participants
Systemic Complications After Treatment Severe intraocular inflammation	5 participants
Systemic Complications After Treatment thromboembolic disease with myocardial infarction	0 participants

Adverse Events

Group 1

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=160 participants at risk 3 year follow-up of intravitreal application of bevacizumab
Eye disorders intraocular inflammation	3.1% 5/160

Other adverse events

Adverse event data not reported

Additional Information

Assoc.Prof.PD.Dr.Stefan Sacu

Medical University of Vienna

Phone: +43404001

Email: stefan.sacu@meduniwien.ac.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place